US Pharm . 2006;6:102-105.    

FDA regulations require that "labeling on or within the package from which the drug is to be dispensed bears adequate information for its use" [(21 CFR § 201.100(c)(1)]. This regulation's intent is to ensure that full prescribing information is available to the pharmacist who dispenses any prescription drug product. As it is physically attached to or contained within the drug packaging, this information is called a medication package insert (PI).

In August 1999, the PhRMA Paperless Labeling Task Force proposed replacing the paper PI with a paperless or electronic version. In its recommendation, the Task Force noted a number of problems with current paper-based approaches in providing pharmacists with full prescribing information.

One problem with paper PIs is accuracy, particularly for drugs with frequent labeling changes. Each year, the FDA requires labeling changes for hundreds of drugs as information is added or altered (i.e., changes to indications, warnings, side effects, dosing recommendations). Thus, when the pharmacist accesses prescribing information using the paper PI or via a standard reference text, he or she may be relying on outdated or incomplete information. Moreover, short of contacting the product's manufacturer, the pharmacist has no way to determine whether the information is current.

PDR On-Demand
One paperless labeling option is Thomson Healthcare's PDR On-Demand. This device consists of a bar code–enabled touch screen monitor about the size and shape of an 8" X 10" picture frame. The stand-alone device is updated daily with current product information via automated dial-in to a database administered by Thomson Healthcare. To retrieve a drug's labeling information, a pharmacist scans the package's bar code or searches the database using the drug's National Drug Code or name on the device's screen.

Beginning September 2004, Thomson Healthcare began a nationwide field trial of PDR On-Demand by placing the device in 88 pharmacies that were selected and randomized by an independent consultant recruited by PhRMA. Although the device was fully functional, it contained labeling information for only 800 prescription drug products. The device was attached to a dedicated printer that allowed the pharmacist to print complete labeling information for a product. In compliance with FDA requirements, pharmacists could print only all or none of the PI, not selected parts. The study assessed pharmacists' attitudes toward--and satisfaction with--PDR On-Demand as an electronic alternative to printed PIs.

Methods
Data were collected via survey from a designated contact pharmacist practicing in each of the 88 pharmacies participating in the field trial. There were 61 chain pharmacies, 26 independent pharmacies, and one government-owned family health center. The pharmacies operated in 24 states and Puerto Rico. Data collection began in December 2004 via surveys faxed to designated contacts at each pharmacy.

Results
Seventy-five pharmacists completed the surveys, for a response rate of 85.2%. Although pharmacists who practiced in chain pharmacy organizations accounted for the majority of respondents, those practicing in clinic, government, and traditional independent community pharmacies had significantly higher response rates in proportion to the chain pharmacists. Because the clinic and government pharmacies closely paralleled the practice settings of independent community pharmacies, they were classified as independently owned pharmacies for all subsequent analyses.

Current Use of Paper PIs: In response to questions regarding how pharmacists use printed PIs, 66 respondents (88%) stated that they discard them. Another six (8%) indicated that they typically give the PI to a patient, and three (4%) stated that they routinely give the PI to other health care professionals.

When respondents were asked how often they refer to the paper PI for drug information, they most frequently stated "once or twice a week" (49.3%), followed by "once or twice a month" (29.3%). Nine respondents (12%) indicated that they refer to the paper PI at least daily, and seven (9.3%) indicated that they almost never refer to it.

When asked why they refer to the paper PI, pharmacists most frequently cited checking the side effects of a drug, followed by checking dosing information, learning about a new product, checking drug interactions, and checking how a drug product is supplied. Chain pharmacists referred to the PI more often than did independent pharmacists for all types of information except checking side effects. However, these differences were not statistically significant (P >.05). As one might expect, frequent PI users referred to the PI more often for all types of information than did infrequent users, although the differences between the two groups were not statistically significant. Respondents also stated that they referred to the PI to check ingredients, including inactive ingredients; review the mechanism of action; check contraindications; and find guidance on splitting tablets.

Comparing Paper PIs to PDR On-Demand: Survey respondents compared the PDR On-Demand device to the paper PI on six usability characteristics. Pharmacists perceived the electronic version to be superior to the paper PI for every characteristic except space requirements for the device and its dedicated printer. Respondents gave particularly high scores for the legibility (i.e., font size, clarity) and ease of use of the electronic device as compared to the paper PI. Although independent pharmacists were more positive than were chain pharmacists, the differences were not statistically significant. Similarly, frequent PI users were more positive than were infrequent users regarding the comparative advantages of the electronic version, but not significantly so.

Regarding whether respondents would be more likely to refer to the PDR On-Demand device than to the printed PI if all FDA-approved drugs were available in the device's database, respondents indicated that they would be moderately more likely to do so. The difference that practice setting made in responses to this question closely approached statistical significance (P = .09), as independent pharmacists scored this question higher than did chain pharmacists. The difference between frequent and infrequent PI users was statistically significant (P = .02), indicating that frequent users of PI information would be more likely than infrequent users to use the electronic device if all drugs were included in the database.

Discussion
Over half (61.3%) of pharmacists who participated in the PDR On-Demand field trial and survey indicated that they refer to PI information at least once a week, and 12% do so on a daily basis. Thus, while the paper PI is discarded most of the time (88%), it continues to be an important and frequently consulted resource for many community pharmacists.

Pharmacists surveyed viewed the PDR On-Demand device as an acceptable--and, in most cases, superior--alternative to paper PIs. Indeed, from October 15, 2004, to February 18, 2005, the average weekly number of labeling inquiries per pharmacy more than doubled--increasing from 45 to 91. This represents a usage increase of about 6% per week during the trial. While the legibility of the information was a particularly important advantage, respondents also viewed the device as superior in speed, accuracy/currency of information, ease of use, and convenience. Moreover, these perceived advantages held across practice setting and frequency of PI use.

The PDR On-Demand compared least favorably with paper PIs in the amount of storage space required. Although the device's footprint is no greater than that required for an 8" ¥ 10" picture frame, it is connected to a dedicated printer (16" wide ¥ 13" deep ¥7" high). Since countertop real estate in the dispensing area of most community pharmacies is a scarce and jealously guarded commodity, the annexation of any territory typically faces opposition by pharmacy staff unless a compelling benefit can be shown. Although it is unlikely the device could be made substantially smaller while retaining some of the features that respondents preferred (e.g., legibility), alternatives could be considered for the dedicated printer or for placement of the unit. For instance, the unit could be wall mounted, and the printer could be stored adjacent to or under the dispensing counter.

Nine respondents complained about their inability to print selected pages or screens of information, as the PDR On-Demand product has only an "all or none" option. Although this option meets FDA requirements, it negates--at least in part--the otherwise "environmentally friendly" nature of the paperless device that was noted by one respondent.

Several respondents noted the need for faster and easier screen navigation and the ability to more easily find a specific topic on the PI, such as information on drug interactions. As this information is contained in a pull-down menu, these comments suggest the need for a more thorough orientation for future users.

While users clearly recognized and valued the superior legibility of information on the device's screen compared to that on the printed PI, two respondents recommended better readability. Although users may increase the screen font size at any time, a larger font size could be used as the default setting and/or users could set their own default font size.

Two respondents suggested adding drug identification, including photos of drugs, and another suggested highlighting information that has changed in an updated PI to allow quick review.

The results of this study suggest that PDR On-Demand is an effective alternative to the paper PI for providing pharmacists with access to full prescribing information on prescription drugs. This product was preferred to paper PIs by pharmacists in every usability characteristic that was studied except for its space requirements. Assuming a future database that includes all marketed prescription drugs, PDR On-Demand is more likely than the printed PI to be used as a resource by community pharmacists.

--Jessica Jannicelli and Abigail Brugger, section editors

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